September 2021 updates

September 17, 2021

Updates from the Human Research Protection Program

The following notice provides updates regarding a new resource for writing exemplary IRB applications, consenting non-English speakers, electronic research signatures, and CITI training courses.

New Resource: iRIS Application Samples

  • The iRIS Help Site now includes examples of well-prepared IRB applications from UCSF researchers. We offer these samples as a reference for how the application can be filled out, and to show some of the different branching paths that the application can take for different types of studies. Please note: MyAccess login is required. Special thanks to the research teams who have allowed us to post their exemplary applications!

Consenting Non-English Speakers

  • The IRB website now outlines the procedures for re-consenting non-English speakers. There is guidance for both the "preferred" and "short-form" methods of re-consent.
  • The Quick Guide on Consenting Non-English Speakers has been updated to specify that use of the “short form” method must be limited to the occasional and unexpected enrollment of a non-English speaking participant. Routine use of this method is strongly discouraged by the University and Federal Regulators. If a study enrolls 2 or more participants that speak the same non-English language, the consent form must be fully translated.

Electronic Research Signatures

  • The IRB website has a new page entitled Part 11 assurances. This page is for researchers conducting FDA-regulated/FDA-funded studies who are using an FDA compliant version of DocuSign or REDCap to collect consent signatures, and offers the following assurances that these eConsent platforms are compliant with FDA’s Part 11 regulations:
    • Memo about Part 11 compliance, signed by Ed Kuczynski, MA, Human Research Protection Program Director
    • Statement on UCSF Compliance with 21 CFR Part 11, signed by Brian Smith, JD, MBA, Chief Ethics and Compliance Officer / Senior Associate Vice Chancellor – Research
  • Our webpage on Research at the SFVA Healthcare System has a new section entitled VA DocuSign. This new section describes how researchers can submit a request to the VA Office of Research & Development (ORD) if they want to use VA DocuSign. It also includes instructions on what to send to the IRB if ORD approves the request.

CITI Training Courses

  • The following CITI training courses are now available in Spanish:
    • GCP Course for Clinical Trials Involving Investigational Medical Devices
    • GCP Course for Trials with Investigational Drugs
    • Good Clinical Practice Course (US FDA focus)
    • Human Subjects Protection Training
    • Revised Common Rule
    • Social & Behavioral Educational Researchers (SBR)
  • A new GCP CITI training completion report is now available on the IRB website. Use this list if you need to check the GCP CITI training status of any Key Study Personnel.